1. Field of the Invention
The present invention relates generally to systems, devices and methods for the treatment of female urinary incontinence, and more particularly, to systems and methods for placing a sub-urethral sling.
2. Description of the Related Art
Women account for more than 11 million incontinence cases, with a majority of those women suffering from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise.
SUI may be caused by a functional defect or weakened tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle and shy away from social situations.
One device and method for treating female urinary stress incontinence is described in detail in U.S. Pat. No. 5,899,909, which is incorporated herein by reference in its entirety. This patent discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which each are connected at one end to respective ends of a mesh intended to be implanted into the body. In practice, the mesh is passed into the body via the vagina first at one end and then at the other end, at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The mesh is extended over the pubis and through the abdominal wall and is tightened. The mesh ends are cut at the abdominal wall, and the mesh is left implanted in the body. This trans-vaginal procedure is exemplified by the TVT product sold by Ethicon Inc., a Johnson & Johnson Company, of Somerville, N.J., USA. In this procedure two 5 mm needles pass a PROLENE mesh trans-vaginally and through the abdomen to create a tension-free support under the mid-urethra.
Sub-urethral slings have also been placed by a different approach wherein a needle is passed first though the abdominal wall along the same path as described above, and eventually exiting through the vaginal incision. The tape is then coupled to the needle in some manner, and pulled back through the body from the vaginal incision and out through the abdominal incision. The chosen approach, vaginal or abdominal, will often depend on the preferences of the surgeon.
Yet another approach for implanting a sub-urethral sling has also been recently developed in which the implanted sling extends from beneath the urethra, and out through the obturator hole on either side. This “transobturator” procedure may involve inserting an appropriately configured needle from a vaginal incision and subsequently out through the obturator hole, or vice versa. The former technique (an “inside-out” approach) and associated instruments are described in detail in U.S. Pat. Nos. 7,611,454, 7,204,802, and 7,261,723, and U.S. Patent Publication No. 2009/0306459, which are incorporated herein by reference in their entirety. As illustrated in U.S. Pat. No. 7,261,723, this technique may be performed using a surgical instrument including a surgical passer or introducer and tube elements applied over the ends of the surgical passers that are coupled to the tape to be implanted under the urethra.
More recently, sub-urethral slings that do not exit the body through the abdominal wall or the buttocks have been developed. These sub-urethral slings, sometimes referred to as “mini slings,” are shorter in length and have ends that are secured inside the body into bone, tissue or the like. One embodiment of a “mini sling” is described in U.S. Pat. No. 7,285,086, the disclosure of which is hereby incorporated by reference herein.
With “mini slings” of this type, proper and accurate positioning of the distal ends within targeted tissue is essential in order to have and maintain the proper amount of support under the urethra to alleviate incontinence. One problem encountered in achieving this is that the ends of the sling must be coupled to some type of insertion device to be placed in position, then subsequently uncoupled from the insertion device so that the insertion device can be withdrawn leaving the implant in place within the body. Known insertion devices for coupling an implant to the insertion device, however, have no attachment mechanisms, have cumbersome attachment mechanisms, and/or require undesirable forces to be applied to uncouple the implant, which, in turn, frequently moves or dislodges the ends of the implant from the targeted and desired position upon uncoupling.
Thus, it would be desirable to provide an improved implant insertion system and surgical insertion devices that minimize or eliminate movement of the implant upon uncoupling of the implant from the insertion device.